Ignite Creation Date:
2024-05-06 @ 2:08 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04228653
Status:
UNKNOWN
Last Update Posted:
2021-03-23
First Post:
2019-08-21
Brief Title:
Long-Term Follow-up Safety After DDS Implantation WithWithout CDNF Infusions
Sponsor:
Renishaw
Organization:
Renishaw
Study Overview
Official Title:
A Long-Term Follow-up Safety Study for Patients With Idiopathic Parkinsons Disease PD Implanted With the DDS andor Who Received Treatment in the Main Study andor Extension Study
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a follow up to the HP-CD-CL-2002 clinical study It evaluates the long-term safety in patients with Parkinsons disease after implantation of an investigational drug delivery system DDS with or without infusions of CDNF All patients will have at least the port explanted
Detailed Description:
A patients participation in the study will last for up to 4 years and will include up to nine visits
Screening 1 visit same as HP-CD-CL-2003 End-of-Study visit
Pre-surgery explantation surgery post-surgery 3 visits
Safety 4 visits
DAT-PET Dopamine Transporter - Positron Emission Tomography examination 1 visit
End-of-study visit 1 visit
Study examinations and assessments
Physical examination pulse rate blood pressure temperature body weight and height body mass index BMI neurological exam
ECG electrocardiography and blood and urine tests
Pregnancy tests for women of childbearing age
Completion of a patient diary to record mobility and time asleep
Parkinsons Kinetigraph PKGTM Data Logger a watch-type movement recording device
Questionnaires rating scales and forms quality of life mood memory impulse control mental health
Magnetic resonance imaging MRI
Positron emission tomography scans PET
Skin condition over any remaining implanted subcutaneous portion of the device
Skin healing after port device removal
For more information httpstreatereuclinical-study
Screening 1 visit same as HP-CD-CL-2003 End-of-Study visit
Pre-surgery explantation surgery post-surgery 3 visits
Safety 4 visits
DAT-PET Dopamine Transporter - Positron Emission Tomography examination 1 visit
End-of-study visit 1 visit
Study examinations and assessments
Physical examination pulse rate blood pressure temperature body weight and height body mass index BMI neurological exam
ECG electrocardiography and blood and urine tests
Pregnancy tests for women of childbearing age
Completion of a patient diary to record mobility and time asleep
Parkinsons Kinetigraph PKGTM Data Logger a watch-type movement recording device
Questionnaires rating scales and forms quality of life mood memory impulse control mental health
Magnetic resonance imaging MRI
Positron emission tomography scans PET
Skin condition over any remaining implanted subcutaneous portion of the device
Skin healing after port device removal
For more information httpstreatereuclinical-study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None